About the Role >>> Submission Content Manager, Regulatory Operations 

The Submission Content Manager plays a critical role within Regulatory Operations by preparing regulatory submission documents for final publishing and delivery to global health authorities. This position ensures that all documents meet technical, formatting, and eCTD (Electronic Common Technical Document) requirements prior to formal submission. The role partners closely with Regulatory Affairs, Medical Writing, CMC, Nonclinical, and Clinical teams to ensure high-quality, compliant, and timely regulatory submissions (e.g., INDs, NDAs, MAAs, amendments). 

The ideal candidate has strong attention to detail, experience with document management and eCTD standards, and the ability to manage multiple concurrent submission activities in a fast-paced environment. 

This role is based out of either our Cambridge, Ma or San Francisco, Ca office and may require up to 15% travel. 

Your work will primarily encompass: 

Document Preparation & Formatting 

• Prepare and format submission-ready documents, including applying PDF standards, bookmarks, hyperlinks, headers/footers, and accessibility elements
• Ensure all documents meet technical standards (e.g., PDF/A compliance, OCR/searchability, file size limits)
• Verify that tracked changes, comments, draft watermarks, and metadata are removed before pre-publishing
• Serve as a subject-matter expert for the Starting Point templates and provide training, guidance, and support to cross-functional teams on how to use these templates effectively

 Submission Assembly Support 

• Assist Regulatory Operations staff in assembling and preparing eCTD sequences for publishing
• Coordinate with submission teams to confirm final document versions and readiness for publishing
• Track and document issues, risks, and deviations, escalating as appropriate
• Work closely with Regulatory Affairs, Medical Writing, CMC, Quality, and Clinical teams to ensure submission accuracy and completeness

Quality Control & Compliance 

• Perform technical QC checks on documents prior to publishing, ensuring formatting, structure, and completeness
• Develop publishing standards and guidelines in coordination with Regulatory Operations and Medical Writing 
• Ensure all pre-publishing activities comply with company SOPs, regulatory guidelines, and eCTD specifications

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s degree is required 
• Knowledge and experience of eCTD submissions 
• Knowledge and experience with enterprise document management systems, preferably Veeva RIM 
• Knowledge and understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking 
• Experience with StartingPoint eCTD templates or equivalent 

 Experience: 

• Minimum 3+ years pharmaceutical industry experience in Regulatory Affairs, Regulatory Operations or Medical Writing
• Demonstrated leadership skills while working in a fast paced and changing environment
• Experience in building and submission of NDA and life-cycle management is highly desirable

Attributes: 

• Displays strong proactive acumen and inclusive way of engagement to drive decision making, turnaround time improvement and effective ways of working 
• Influences the cross-functional team to adapt fit-for purpose solutions to meet the expected timelines 
• Ability to understand, analyze and develop recommendations from multiple complex sources such as scientific and operational perspectives  
• Excellent written and verbal communication skills 
• Excellent negotiation and organizational skills 

The base pay range for this position is expected to be $145,000 - $155,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

About the Role >>> Senior Director, Global Regulatory Strategy 

As the Senior Director, Global Regulatory Strategy reporting to the Senior Vice President of Regulatory Affairs, your main responsibilities will include the following:  

• Leading the development and execution of innovative regulatory strategies supporting Olema products  
• Representing Regulatory Affairs on cross-functional teams as the subject matter expert and providing regulatory guidance and oversight to the global project teams
• Providing strategic and tactical guidance and leading the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, IMPD etc.)  

This role is based either out of our Boston, MA or San Francisco, CA office and will require domestic and international travel up to 20%. 

Your work will primarily encompass:  

• Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed  
• Represent Regulatory Affairs as the SME across cross-functional teams and provide regulatory guidance/oversight to the global project teams, Study Execution Teams, and the Executive Committee  
• Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices (e.g., companion diagnostics)  
• Be accountable for, provide both strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DSUR, IMPD etc.)  
• Represent Olema with global Health Authorities and lead Agency interactions to achieve company objectives  
• Proactively identify gaps and develop risk mitigation strategies for regulatory submissions in alignment with the team(s) and management 
• Ensure Olema’s regulatory activities are robust and in compliance with Health Authority (HA) regulatory requirements  
• Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams  
• Serve as the point of contact with external parties and vendors supporting regulatory activities (e.g., CROs, contractors etc)   
• Participate in and contribute to cross-functional and departmental objectives  
• Maintain flexibility to adapt and accommodate additional duties as assigned  

And will also include the following:  

• Lead the development of Regulatory Affairs department policies, SOPs, and work instructions  
• Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva)  
• Keep the Leadership and the organization fully informed of the regulatory landscape, including HA initiatives, policies and their potential impact on Olema’s programs  
• Lead the global Regulatory team(s) and ensure execution of the regulatory strategies to achieve company objectives  
• Mentor and develop colleagues in the Regulatory department   

Ideal Candidate Profile  >>> Innovative Experienced Regulatory Strategy Leader  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.  

Knowledge:  

• Bachelor’s degree in a scientific discipline  
• Advanced degree in scientific discipline Masters, Pharm D or PhD is preferred   

Experience:  

• 12 years’ experience in Regulatory Affairs in Pharma/Biotech  
• Minimum of 3 years direct leadership experience  
• Strong negotiation skills with health authorities (viz., FDA, EMA, Health Canada, etc.) as well as submissions  
• Experience with leading the NDA/BLA or Marketing Applications is desirable.) 
• Experience in Oncology Therapeutic area is required 
• Experience with development and execution of regulatory strategies in Oncology TA is required  
• Ability to work in a fast-paced environment in a hands-on fashion  
• Excellent oral, written, and presentation skills  
• Strong organizational skills  

Attributes:  

• Self-starter  
• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities

The base pay range for this position is expected to be $270,000 - $290,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-MK1

About the Role >>> Senior Director, Global Regulatory Strategy 

As the Senior Director, Global Regulatory Strategy reporting to the Senior Vice President of Regulatory Affairs, your main responsibilities will include the following:  

• Leading the development and execution of innovative regulatory strategies supporting Olema products  
• Representing Regulatory Affairs on cross-functional teams as the subject matter expert and providing regulatory guidance and oversight to the global project teams
• Providing strategic and tactical guidance and leading the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, IMPD etc.)  

This role is based either out of our Boston, MA or San Francisco, CA office and will require domestic and international travel up to 20%. 

Your work will primarily encompass:  

• Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed  
• Represent Regulatory Affairs as the SME across cross-functional teams and provide regulatory guidance/oversight to the global project teams, Study Execution Teams, and the Executive Committee  
• Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices (e.g., companion diagnostics)  
• Be accountable for, provide both strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DSUR, IMPD etc.)  
• Represent Olema with global Health Authorities and lead Agency interactions to achieve company objectives  
• Proactively identify gaps and develop risk mitigation strategies for regulatory submissions in alignment with the team(s) and management 
• Ensure Olema’s regulatory activities are robust and in compliance with Health Authority (HA) regulatory requirements  
• Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams  
• Serve as the point of contact with external parties and vendors supporting regulatory activities (e.g., CROs, contractors etc)   
• Participate in and contribute to cross-functional and departmental objectives  
• Maintain flexibility to adapt and accommodate additional duties as assigned  

And will also include the following:  

• Lead the development of Regulatory Affairs department policies, SOPs, and work instructions  
• Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva)  
• Keep the Leadership and the organization fully informed of the regulatory landscape, including HA initiatives, policies and their potential impact on Olema’s programs  
• Lead the global Regulatory team(s) and ensure execution of the regulatory strategies to achieve company objectives  
• Mentor and develop colleagues in the Regulatory department   

Ideal Candidate Profile  >>> Innovative Experienced Regulatory Strategy Leader  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.  

Knowledge:  

• Bachelor’s degree in a scientific discipline  
• Advanced degree in scientific discipline Masters, Pharm D or PhD is preferred   

Experience:  

• 12 years’ experience in Regulatory Affairs in Pharma/Biotech  
• Minimum of 3 years direct leadership experience  
• Strong negotiation skills with health authorities (viz., FDA, EMA, Health Canada, etc.) as well as submissions  
• Experience with leading the NDA/BLA or Marketing Applications is desirable.) 
• Experience in Oncology Therapeutic area is required 
• Experience with development and execution of regulatory strategies in Oncology TA is required  
• Ability to work in a fast-paced environment in a hands-on fashion  
• Excellent oral, written, and presentation skills  
• Strong organizational skills  

Attributes:  

• Self-starter  
• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities

The base pay range for this position is expected to be $270,000 - $290,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-MK1

About the Role >>> Associate Director, GCP Quality Assurance   

As the Associate Director, GCP Quality Assurance, reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance. This will include identifying and communicating clinical trial-related risks and opportunities for process improvement, as well as reviewing / approving study-related documents and plans and supporting audits.  

This hybrid role is based out of either our San Francisco, CA or Cambridge, MA office and requires up to 20% travel. 

Your work will primarily encompass: 

• Performs internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines 
• Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders  
• Partner with QA leadership during regulatory authority inspections and drive  GxP inspection readiness activities 
• Oversees quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP 
• Prepare for health authority inspections, suppliers and or clinical sites 
• Oversee clinical compliance and quality within the context of cross-functional study teams 
• Continue to improve/refine Olema’s risk-based GCP compliance approach globally 
• Manage Quality Management System (QMS) including, but not be limited to, the following activities: QA review/approval of deviations, CAPAs and change controls 
• Draft, review, and approve policies, procedures, and work instructions 

Ideal Candidate Profile >>> Key Requirements 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s Degree or higher in a scientific discipline 
• Strong understanding of clinical trials and pharmacovigilance reporting  
• In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 
• Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.) 

Experience: 

• A minimum of 8 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment 
• Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk-based audit plans 
• Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors 
• Hands-on experience with regulatory inspections and inspection readiness activities 
• Experience writing and reviewing SOPs 
• Experience using QMS (Veeva systems preferred) 
• Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations. In addition, preferred Good Laboratory Practice (GLP) experience 
• Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 

Attributes: 

• Excellent verbal and written communication skills 
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members 
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects 
• Ability to work hands-on and be a strong individual contributor 

The base pay range for this position is expected to be $190,000 - $205,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

About the Role >>> Associate Director, GCP Quality Assurance   

As the Associate Director, GCP Quality Assurance, reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance. This will include identifying and communicating clinical trial-related risks and opportunities for process improvement, as well as reviewing / approving study-related documents and plans and supporting audits.  

This hybrid role is based out of either our San Francisco, CA or Cambridge, MA office and requires up to 20% travel. 

Your work will primarily encompass: 

• Performs internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines 
• Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders  
• Partner with QA leadership during regulatory authority inspections and drive  GxP inspection readiness activities 
• Oversees quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP 
• Prepare for health authority inspections, suppliers and or clinical sites 
• Oversee clinical compliance and quality within the context of cross-functional study teams 
• Continue to improve/refine Olema’s risk-based GCP compliance approach globally 
• Manage Quality Management System (QMS) including, but not be limited to, the following activities: QA review/approval of deviations, CAPAs and change controls 
• Draft, review, and approve policies, procedures, and work instructions 

Ideal Candidate Profile >>> Key Requirements 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s Degree or higher in a scientific discipline 
• Strong understanding of clinical trials and pharmacovigilance reporting  
• In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 
• Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.) 

Experience: 

• A minimum of 8 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment 
• Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk-based audit plans 
• Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors 
• Hands-on experience with regulatory inspections and inspection readiness activities 
• Experience writing and reviewing SOPs 
• Experience using QMS (Veeva systems preferred) 
• Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations. In addition, preferred Good Laboratory Practice (GLP) experience 
• Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 

Attributes: 

• Excellent verbal and written communication skills 
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members 
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects 
• Ability to work hands-on and be a strong individual contributor 

The base pay range for this position is expected to be $190,000 - $205,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

About the Role >>> Vice President, Quality Assurance  

The Vice President, Quality Assurance serves as the senior leader accountable for defining and driving Olema’s global quality strategy, systems, and governance across the full product lifecycle, including clinical development, manufacturing, pharmacovigilance, and commercial. This leader is the primary voice of Quality at the executive level and ensures a phase-appropriate, risk-based approach to quality that reflects the needs of oncology drug development, where patient safety, data integrity, and speed are critical.  

Operating with appropriate independence, this role partners cross-functionally and leads an established Quality leadership team across GCP, GMP, and GPV - aligning priorities, strengthening execution, and ensuring inspection readiness as Olema advances toward late-stage development.

This role is based out of our either our San Francisco, CA or Boston, MA office and will require some travel as needed.  

As Vice President, Quality Assurance, your work will primarily encompass:

Quality Strategy & Leadership  

• Define and drive a pragmatic, phase-appropriate and unified Quality strategy aligned with Olema’s pipeline and corporate objectives   
• Serve as the senior Quality leader, establishing clear governance, decision-making frameworks, and escalation pathways   
• Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong execution and maintaining clear accountability   
• Foster a culture of quality, integrity, and patient focus across the organization   
• Act as escalation point for significant quality, compliance, and patient safety risks   
• Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains 

Quality Systems & Governance  

• Set expectations and direction for a scalable, integrated, and sustainable Quality Management framework spanning clinical through commercial stages   
• Ensure effectiveness and evolution of Quality systems through oversight of functional leaders across the QA function   
• Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization   
• Establish clear quality metrics and reporting to enable risk visibility and informed decision-making 

Clinical Quality (GCP)  

• Ensure Quality approaches appropriately support the execution of oncology clinical trials   
• Provide oversight of clinical quality and CRO management to ensure patient safety and data integrity   
• Partner with Clinical and Regulatory to support inspection-ready programs and submissions

Manufacturing & Commercial Readiness (GMP)  

• Ensure Quality strategy supports manufacturing scale-up and readiness for late-stage development and commercialization   
• Oversee GMP Quality through established leadership, ensuring appropriate CMO/CDMO oversight and inspection preparedness   
• Provide Quality input into CMC, validation, and supply chain readiness activities

Pharmacovigilance Quality (GPV)  

• Oversee the pharmacovigilance quality framework, ensuring compliance, data integrity, and effective safety surveillance   
• Ensure PV systems and vendors are appropriately governed and inspection-ready   
• Partner cross-functionally to support ongoing evaluation of benefit-risk

Inspection, Audit & Risk Management  

• Lead the Company’s approach to regulatory inspections, including preparation and execution   
• Ensure risk-based audit programs across GCP, GMP, and GPV   
• Drive proactive identification and mitigation of quality and compliance risks

Cross-Functional Leadership  

• Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing, to embed quality across the organization   
• Provide clear, actionable Quality perspectives to support business decisions   
• Represent Quality in executive discussions and external engagements as needed   

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge

• Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS) 
• Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (GPV) regulatory requirement 
• Expertise across GCP, GMP, and GPV Quality domains 
• Strong understanding of Quality systems, governance, and inspection readiness practices 
• Working knowledge of oncology drug development

Experience

• Minimum of 15+ years of Quality experience in biotech/pharma with increasing scope and responsibility 
• Significant people management and leadership experience, including leading senior team members 
• Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and PV vendors 
• Demonstrated experience across GCP, GMP, and GPV environments 
• Proven track record supporting programs from clinical development through late-stage or commercial readiness 
• Experience leading regulatory inspections and interacting with global health authorities 
• Experience implementing and maintaining Quality systems and compliance frameworks

Attributes

• Strong leadership capability with ability to lead through and develop senior leaders 
• Effective communicator with executive presence and influencing skills 
• Sound judgment and decision-making in complex, risk-based environments 
• Ability to operate effectively in a fast-paced, evolving biotech environment 
• Commitment to quality, compliance, and patient safety 

The base pay range for this position is expected to be $315,000 - $340,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-AD1

About the Role >>> Vice President, Quality Assurance  

The Vice President, Quality Assurance serves as the senior leader accountable for defining and driving Olema’s global quality strategy, systems, and governance across the full product lifecycle, including clinical development, manufacturing, pharmacovigilance, and commercial. This leader is the primary voice of Quality at the executive level and ensures a phase-appropriate, risk-based approach to quality that reflects the needs of oncology drug development, where patient safety, data integrity, and speed are critical.  

Operating with appropriate independence, this role partners cross-functionally and leads an established Quality leadership team across GCP, GMP, and GPV - aligning priorities, strengthening execution, and ensuring inspection readiness as Olema advances toward late-stage development.

This role is based out of our either our San Francisco, CA or Boston, MA office and will require some travel as needed.  

As Vice President, Quality Assurance, your work will primarily encompass:

Quality Strategy & Leadership  

• Define and drive a pragmatic, phase-appropriate and unified Quality strategy aligned with Olema’s pipeline and corporate objectives   
• Serve as the senior Quality leader, establishing clear governance, decision-making frameworks, and escalation pathways   
• Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong execution and maintaining clear accountability   
• Foster a culture of quality, integrity, and patient focus across the organization   
• Act as escalation point for significant quality, compliance, and patient safety risks   
• Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains 

Quality Systems & Governance  

• Set expectations and direction for a scalable, integrated, and sustainable Quality Management framework spanning clinical through commercial stages   
• Ensure effectiveness and evolution of Quality systems through oversight of functional leaders across the QA function   
• Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization   
• Establish clear quality metrics and reporting to enable risk visibility and informed decision-making 

Clinical Quality (GCP)  

• Ensure Quality approaches appropriately support the execution of oncology clinical trials   
• Provide oversight of clinical quality and CRO management to ensure patient safety and data integrity   
• Partner with Clinical and Regulatory to support inspection-ready programs and submissions

Manufacturing & Commercial Readiness (GMP)  

• Ensure Quality strategy supports manufacturing scale-up and readiness for late-stage development and commercialization   
• Oversee GMP Quality through established leadership, ensuring appropriate CMO/CDMO oversight and inspection preparedness   
• Provide Quality input into CMC, validation, and supply chain readiness activities

Pharmacovigilance Quality (GPV)  

• Oversee the pharmacovigilance quality framework, ensuring compliance, data integrity, and effective safety surveillance   
• Ensure PV systems and vendors are appropriately governed and inspection-ready   
• Partner cross-functionally to support ongoing evaluation of benefit-risk

Inspection, Audit & Risk Management  

• Lead the Company’s approach to regulatory inspections, including preparation and execution   
• Ensure risk-based audit programs across GCP, GMP, and GPV   
• Drive proactive identification and mitigation of quality and compliance risks

Cross-Functional Leadership  

• Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing, to embed quality across the organization   
• Provide clear, actionable Quality perspectives to support business decisions   
• Represent Quality in executive discussions and external engagements as needed   

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge

• Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS) 
• Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (GPV) regulatory requirement 
• Expertise across GCP, GMP, and GPV Quality domains 
• Strong understanding of Quality systems, governance, and inspection readiness practices 
• Working knowledge of oncology drug development

Experience

• Minimum of 15+ years of Quality experience in biotech/pharma with increasing scope and responsibility 
• Significant people management and leadership experience, including leading senior team members 
• Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and PV vendors 
• Demonstrated experience across GCP, GMP, and GPV environments 
• Proven track record supporting programs from clinical development through late-stage or commercial readiness 
• Experience leading regulatory inspections and interacting with global health authorities 
• Experience implementing and maintaining Quality systems and compliance frameworks

Attributes

• Strong leadership capability with ability to lead through and develop senior leaders 
• Effective communicator with executive presence and influencing skills 
• Sound judgment and decision-making in complex, risk-based environments 
• Ability to operate effectively in a fast-paced, evolving biotech environment 
• Commitment to quality, compliance, and patient safety 

The base pay range for this position is expected to be $315,000 - $340,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-AD1

About the Role >>> Director, Clinical Monitoring Oversight 

As the Director, Clinical Monitoring Oversight, reporting to the Senior Director, Clinical Operations, you will provide strategic and operational leadership for global clinical site monitoring activities across Olema’s clinical programs. You will ensure that clinical monitoring – whether by internal teams, through Functional Service Providers (FSPs), or outsourced to Clinical Research Organizations (CROs) – is executed with high standards of quality and consistency while maintaining compliance with GCP regulations. You will oversee Olema’s Clinical Monitoring Oversight Leads, regional monitoring teams, and site performance. As the Director, Clinical Monitoring Oversight, you will develop and implement monitoring oversight strategies and standards for Olema’s clinical monitoring execution worldwide—driving operational excellence, data integrity, and inspection readiness across all trials with an emphasis on risk-based, data driven processes. 

This role is based out of either our Boston, MA or San Francisco, CA office and will require about travel 15% travel.  

Your work will primarily encompass: 

• Provide strategic direction and operational oversight of all global monitoring activities across Olema’s clinical programs 
• Oversee internal clinical monitoring oversight team and FSP vendor responsible for providing Regional Site Monitoring Leads (RSMLs), ensuring alignment, consistency, and accountability across global regions 
• Establish and maintain effective governance with the FSP partner, including performance management, risk mitigation, and continuous improvement in monitoring quality and efficiency 
• Define and implement Olema’s monitoring strategy, including risk-based and centralized monitoring approaches in alignment with ICH-GCP and regulatory expectations 
• Ensure global harmonization of clinical monitoring processes, training, and documentation across programs and regions 
• Develop and monitor key performance indicators (KPIs) and quality metrics to evaluate site performance, FSP delivery, and regional oversight effectiveness 
• Collaborate with Clinical Operations, Data Management, Clinical Quality, and Clinical Development to ensure monitoring activities are aligned with program objectives and timelines 
• Contribute to the development and review of key operational documents, including Monitoring Plans, Oversight Plans, Risk Management Plans, and audit/inspection responses 
• Proactively assess monitoring risks and implement mitigation strategies to maintain inspection readiness 
• Lead, manage, and mentor internal monitoring oversight staff, fostering collaboration, accountability, and continuous improvement 
• Serve as the Monitoring Oversight representative on cross-functional and governance teams, presenting program updates, risks, and mitigation strategies to senior management 
• Drive innovation and process optimization in monitoring oversight practices, including leveraging technology and data analytics to enhance quality and efficiency 

 Ideal Candidate Profile >>> 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor's or Master’s degree in a scientific discipline or a related scientific field is required 
• Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements related to monitoring and clinical trial conduct 

 Experience: 

• Minimum 12 years of clinical operations experience in the pharmaceutical or biotech industry 
• Minimum 5 years direct site monitoring experience (qualification, initiation, interim, and close-out visits) with strong understanding of site operations and clinical trial execution 
• Minimum 5 years in a role providing global monitoring oversight, including oversight of clinical site monitors, FSP/CRO management and oversight, monitoring quality metrics, KPIs, and governance, and a track record of driving performance improvement and corrective action plans 
• Experience overseeing regional monitoring functions and ensuring alignment across geographically distributed teams 
• Oncology experience is required  

 Attributes: 

• Demonstrated ability to manage FSP or CRO partnerships, including contract governance, KPI development, and issue escalation 
• Skilled in risk-based monitoring methodologies and the use of oversight tools and systems 
• Strategic thinker with excellent communication, leadership, and interpersonal skills, with the ability to influence cross-functionally and externally 
• Strong analytical and problem-solving abilities; adept at managing competing priorities in a fast-paced environment 

The base pay range for this position is expected to be $235,000 - $250,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

About the Role >>> Director, Clinical Monitoring Oversight 

As the Director, Clinical Monitoring Oversight, reporting to the Senior Director, Clinical Operations, you will provide strategic and operational leadership for global clinical site monitoring activities across Olema’s clinical programs. You will ensure that clinical monitoring – whether by internal teams, through Functional Service Providers (FSPs), or outsourced to Clinical Research Organizations (CROs) – is executed with high standards of quality and consistency while maintaining compliance with GCP regulations. You will oversee Olema’s Clinical Monitoring Oversight Leads, regional monitoring teams, and site performance. As the Director, Clinical Monitoring Oversight, you will develop and implement monitoring oversight strategies and standards for Olema’s clinical monitoring execution worldwide—driving operational excellence, data integrity, and inspection readiness across all trials with an emphasis on risk-based, data driven processes. 

This role is based out of either our Boston, MA or San Francisco, CA office and will require about travel 15% travel.  

Your work will primarily encompass: 

• Provide strategic direction and operational oversight of all global monitoring activities across Olema’s clinical programs 
• Oversee internal clinical monitoring oversight team and FSP vendor responsible for providing Regional Site Monitoring Leads (RSMLs), ensuring alignment, consistency, and accountability across global regions 
• Establish and maintain effective governance with the FSP partner, including performance management, risk mitigation, and continuous improvement in monitoring quality and efficiency 
• Define and implement Olema’s monitoring strategy, including risk-based and centralized monitoring approaches in alignment with ICH-GCP and regulatory expectations 
• Ensure global harmonization of clinical monitoring processes, training, and documentation across programs and regions 
• Develop and monitor key performance indicators (KPIs) and quality metrics to evaluate site performance, FSP delivery, and regional oversight effectiveness 
• Collaborate with Clinical Operations, Data Management, Clinical Quality, and Clinical Development to ensure monitoring activities are aligned with program objectives and timelines 
• Contribute to the development and review of key operational documents, including Monitoring Plans, Oversight Plans, Risk Management Plans, and audit/inspection responses 
• Proactively assess monitoring risks and implement mitigation strategies to maintain inspection readiness 
• Lead, manage, and mentor internal monitoring oversight staff, fostering collaboration, accountability, and continuous improvement 
• Serve as the Monitoring Oversight representative on cross-functional and governance teams, presenting program updates, risks, and mitigation strategies to senior management 
• Drive innovation and process optimization in monitoring oversight practices, including leveraging technology and data analytics to enhance quality and efficiency 

 Ideal Candidate Profile >>> 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor's or Master’s degree in a scientific discipline or a related scientific field is required 
• Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements related to monitoring and clinical trial conduct 

 Experience: 

• Minimum 12 years of clinical operations experience in the pharmaceutical or biotech industry 
• Minimum 5 years direct site monitoring experience (qualification, initiation, interim, and close-out visits) with strong understanding of site operations and clinical trial execution 
• Minimum 5 years in a role providing global monitoring oversight, including oversight of clinical site monitors, FSP/CRO management and oversight, monitoring quality metrics, KPIs, and governance, and a track record of driving performance improvement and corrective action plans 
• Experience overseeing regional monitoring functions and ensuring alignment across geographically distributed teams 
• Oncology experience is required  

 Attributes: 

• Demonstrated ability to manage FSP or CRO partnerships, including contract governance, KPI development, and issue escalation 
• Skilled in risk-based monitoring methodologies and the use of oversight tools and systems 
• Strategic thinker with excellent communication, leadership, and interpersonal skills, with the ability to influence cross-functionally and externally 
• Strong analytical and problem-solving abilities; adept at managing competing priorities in a fast-paced environment 

The base pay range for this position is expected to be $235,000 - $250,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

About the Role >>> Lead Senior Medical Writer 

As the Lead Senior Medical Writer, reporting to the Director of Medical Writing, you will lead the development, and delivery of high-quality scientific and regulatory documents supporting Olema’s oncology portfolio. This role requires strong cross-functional leadership, partnering closely with Clinical Science, Clinical Development, Regulatory Affairs, Biometrics, and other stakeholders to translate complex clinical and preclinical data into clear, accurate, and compelling content for regulatory submissions, medical communications, and scientific publications. In addition, you will drive consistency, quality, and timelines across deliverables, contributing to the overall medical writing strategy and supporting key regulatory and clinical milestones. 

This role is based out of our Boston, MA or San Francisco, CA office and will require 10-15% travel. 

Your work will primarily encompass: 

• Preparing and editing a wide range of scientific and medical writing deliverables, including but not limited to protocols, protocol amendments, clinical study protocols, investigator brochures, regulatory submission documents (e.g. IBs, DSURs, sections of IND/IMPD/MAAs), PowerPoint presentations related to the Medical Writing function
• Collaborating with internal stakeholders (clinical scientists, regulatory strategy, medical monitors, biometrics, medical affairs) to understand data, interpret results, and ensure accurate message conveyance
• Ensuring documents adhere to internal style guidelines, regulatory requirements (e.g., ICH, GPP), and appropriate therapeutic-area standards (e.g., oncology, breast cancer)
• Maintaining version control, track author/reviewer feedback, and delivering documents according to project timelines
• Providing  writing and/or QC editing support for associated submission documents (as applicable) to help elevate overall team deliverables
• Remaining current on therapeutic area (breast cancer / endocrine-driven tumors) trends, journal publications, and regulatory guidance relevant to oncology and women’s cancers

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree (MS/PharmD/PhD) preferred
• Demonstrated and excellent scientific writing and editing skills — the ability to translate complex scientific data into clear, concise, accurate documents for varied audiences (regulatory agencies, KOLs, internal stakeholders)
• Familiarity with regulatory writing standards (e.g., ICH E3/E6, GPP)
• Oncology preferred 
• Veeva RIM experience is a plus 

Experience: 

• Minimum of 7+ years of medical or regulatory writing experience, oncology (especially breast cancer) preferred, or a closely related therapeutic area
• Strong project management skills: able to manage multiple deliverables, meet deadlines, handle feedback iterations, and coordinate with cross-functional teams
• Ability to work independently with minimal supervision, while also being a collaborative team player
• Detail-oriented, organized, with strong verbal communication skills
• Proficiency with standard technical and document-management tools (e.g., Microsoft Word, PowerPoint, Microsoft Excel, Smartsheet, Starting Point Templates, Veeva RIM)
• Prior experience in clinical-trial documentation for oncology (eg, IBs, protocols, DSUR and CSRs) preferred
• Experience working in hybrid/remote environments

Attributes: 

• Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
• Self-motivated and enthusiastic; fast learner who can identify project challenges and expeditiously change course as required in a fast-paced organization
• Strong communicator who can tailor messaging to diverse audiences
• Highly organized with strong attention to detail and follow-through
• Ability in building strong cross functional working relationships 

The base pay range for this position is expected to be $160,000-$175,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MT1

About the Role >>> Lead Senior Medical Writer

As the Lead Senior Medical Writer, reporting to the Director of Medical Writing, you will lead the development, and delivery of high-quality scientific and regulatory documents supporting Olema’s oncology portfolio. This role requires strong cross-functional leadership, partnering closely with Clinical Science, Clinical Development, Regulatory Affairs, Biometrics, and other stakeholders to translate complex clinical and preclinical data into clear, accurate, and compelling content for regulatory submissions, medical communications, and scientific publications. In addition, you will drive consistency, quality, and timelines across deliverables, contributing to the overall medical writing strategy and supporting key regulatory and clinical milestones. 

This role is based out of our Boston, MA or San Francisco, CA office and will require 10-15% travel. 

Your work will primarily encompass: 

• Preparing and editing a wide range of scientific and medical writing deliverables, including but not limited to protocols, protocol amendments, clinical study protocols, investigator brochures, regulatory submission documents (e.g. IBs, DSURs, sections of IND/IMPD/MAAs), PowerPoint presentations related to the Medical Writing function
• Collaborating with internal stakeholders (clinical scientists, regulatory strategy, medical monitors, biometrics, medical affairs) to understand data, interpret results, and ensure accurate message conveyance
• Ensuring documents adhere to internal style guidelines, regulatory requirements (e.g., ICH, GPP), and appropriate therapeutic-area standards (e.g., oncology, breast cancer)
• Maintaining version control, track author/reviewer feedback, and delivering documents according to project timelines
• Providing  writing and/or QC editing support for associated submission documents (as applicable) to help elevate overall team deliverables
• Remaining current on therapeutic area (breast cancer / endocrine-driven tumors) trends, journal publications, and regulatory guidance relevant to oncology and women’s cancers

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree (MS/PharmD/PhD) preferred
• Demonstrated and excellent scientific writing and editing skills — the ability to translate complex scientific data into clear, concise, accurate documents for varied audiences (regulatory agencies, KOLs, internal stakeholders)
• Familiarity with regulatory writing standards (e.g., ICH E3/E6, GPP)
• Oncology preferred 
• Veeva RIM experience is a plus 

Experience: 

• Minimum of 7+ years of medical or regulatory writing experience, oncology (especially breast cancer) preferred, or a closely related therapeutic area
• Strong project management skills: able to manage multiple deliverables, meet deadlines, handle feedback iterations, and coordinate with cross-functional teams
• Ability to work independently with minimal supervision, while also being a collaborative team player
• Detail-oriented, organized, with strong verbal communication skills
• Proficiency with standard technical and document-management tools (e.g., Microsoft Word, PowerPoint, Microsoft Excel, Smartsheet, Starting Point Templates, Veeva RIM)
• Prior experience in clinical-trial documentation for oncology (eg, IBs, protocols, DSUR and CSRs) preferred
• Experience working in hybrid/remote environments

Attributes: 

• Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
• Self-motivated and enthusiastic; fast learner who can identify project challenges and expeditiously change course as required in a fast-paced organization
• Strong communicator who can tailor messaging to diverse audiences
• Highly organized with strong attention to detail and follow-through
• Ability in building strong cross functional working relationships 

The base pay range for this position is expected to be $160,000-$175,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MT1

About the Role >>> Associate Director, Global Regulatory Strategy - International 

As Associate Director, Global Regulatory Strategy / International Regulatory Affairs, reporting to the Senior Director of Regulatory Affairs Strategy, you will contribute to the development and execution of regulatory strategies for Olema’s products in early to late-stage clinical development. You will represent Regulatory Affairs on cross-functional teams, lead the planning and preparation of clinical trial submissions (INDs, CTAs, amendments, briefing documents, Investigator Brochures) and support global health authority interactions.  

This role can be based out of our Boston, MA or San Francisco, CA office and will require domestic and international travel, approximately 10–15%

Your Work Will Primarily Encompass: 

• With limited supervision, support the development and execution of global regulatory strategies for products in Olema’s pipeline, with a focus on early development and clinical trial applications
• Serve as the Regulatory Affairs representative on global project teams and Study Execution Teams, providing regulatory input and ensuring alignment with program objectives and timelines
• Prepare and coordinate high-quality regulatory global submissions, including INDs, CTAs, amendments, annual reports, DSURs, Investigator Brochures, and briefing documents
• Under the supervision of the Senior Director, Regulatory Affairs, contribute to planning and execution of regulatory interactions with health authorities (e.g., FDA, EMA, Health Canada, MHRA), including meeting requests, briefing packages, and follow-up correspondence
• Monitor the global regulatory landscape to identify requirements, trends, and potential impact on Olema’s development programs
• Coordinate and maintain health authority reporting schedules in collaboration with cross-functional teams
• Partner with external vendors (e.g., CROs, regulatory consultants) to ensure high-quality and timely submissions
• Support development of Regulatory Affairs departmental policies, SOPs, and systems (e.g., Veeva) to enhance submission quality and efficiency
• Assist in risk assessment and mitigation planning for regulatory deliverables

Ideal Candidate Profile  

We are looking for a collaborative and driven Regulatory Affairs professional who thrives in a fast-paced environment and brings expertise in regulatory strategy

Knowledge: 

Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred

Experience: 

• Minimum 10 years of related experience with a Bachelor’s degree; or 7 years and a Master’s degree; or a PhD with 5 years experience; regulatory affairs experience in the pharmaceutical or biotechnology industry
• Direct experience preparing and submitting clinical trial applications (INDs, CTAs) and managing regulatory authority correspondence 
• Knowledge of global regulatory requirements for clinical development (FDA, EMA, ICH guidelines)
• Oncology therapeutic area experience preferred
• Experience collaborating in cross-functional, matrixed teams 
• Experience working withCROs and other partners

Attributes: 

• Strong organizational, project management, and problem-solving skills
• Excellent oral, written, and presentation skills
• Flexible and proactive, with the ability to manage multiple projects and adapt to changing priorities
• Self-starter with the ability to work both independently and within teams

The base pay range for this position is expected to be $176,000 - $188,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MK1

About the Role >>> Associate Director, Global Regulatory Strategy - International 

As Associate Director, Global Regulatory Strategy / International Regulatory Affairs, reporting to the Senior Director of Regulatory Affairs Strategy, you will contribute to the development and execution of regulatory strategies for Olema’s products in early to late-stage clinical development. You will represent Regulatory Affairs on cross-functional teams, lead the planning and preparation of clinical trial submissions (INDs, CTAs, amendments, briefing documents, Investigator Brochures) and support global health authority interactions.  

This role can be based out of our Boston, MA or San Francisco, CA office and will require domestic and international travel, approximately 10–15%

Your Work Will Primarily Encompass: 

• With limited supervision, support the development and execution of global regulatory strategies for products in Olema’s pipeline, with a focus on early development and clinical trial applications
• Serve as the Regulatory Affairs representative on global project teams and Study Execution Teams, providing regulatory input and ensuring alignment with program objectives and timelines
• Prepare and coordinate high-quality regulatory global submissions, including INDs, CTAs, amendments, annual reports, DSURs, Investigator Brochures, and briefing documents
• Under the supervision of the Senior Director, Regulatory Affairs, contribute to planning and execution of regulatory interactions with health authorities (e.g., FDA, EMA, Health Canada, MHRA), including meeting requests, briefing packages, and follow-up correspondence
• Monitor the global regulatory landscape to identify requirements, trends, and potential impact on Olema’s development programs
• Coordinate and maintain health authority reporting schedules in collaboration with cross-functional teams
• Partner with external vendors (e.g., CROs, regulatory consultants) to ensure high-quality and timely submissions
• Support development of Regulatory Affairs departmental policies, SOPs, and systems (e.g., Veeva) to enhance submission quality and efficiency
• Assist in risk assessment and mitigation planning for regulatory deliverables

Ideal Candidate Profile  

We are looking for a collaborative and driven Regulatory Affairs professional who thrives in a fast-paced environment and brings expertise in regulatory strategy

Knowledge: 

Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred

Experience: 

• Minimum 10 years of related experience with a Bachelor’s degree; or 7 years and a Master’s degree; or a PhD with 5 years experience; regulatory affairs experience in the pharmaceutical or biotechnology industry
• Direct experience preparing and submitting clinical trial applications (INDs, CTAs) and managing regulatory authority correspondence 
• Knowledge of global regulatory requirements for clinical development (FDA, EMA, ICH guidelines)
• Oncology therapeutic area experience preferred
• Experience collaborating in cross-functional, matrixed teams 
• Experience working with CROs and other partners

Attributes: 

• Strong organizational, project management, and problem-solving skills
• Excellent oral, written, and presentation skills
• Flexible and proactive, with the ability to manage multiple projects and adapt to changing priorities
• Self-starter with the ability to work both independently and within teams

The base pay range for this position is expected to be $176,000 - $188,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MK1

About the Role >>> Senior Manager, Quality Document Control and Compliance 

The Senior Manager, Quality Document Control and Compliance will report to the Director, Quality Systems and lead and manage the daily activities of Veeva Vault QDocs and overall document management process and compliance. This role includes but not limited to: creation and processing of document change control documentation in Veeva QDocs, management of standard operating procedures (SOPs) and other GXP documentation, GXP record processing and archival, maintain document control compliance KPIs and compile and report metrics for management review. 

This role is based out of our San Francisco, CA or Cambridge, MA office and will require about 15% travel. 

Your work will primarily encompass: 

• Serving as Veeva Vault QDocs Administrator and document control manager  
• Processing document change control (DCC) in Veeva for GxP controlled documents
• Formatting the finalized documents to ensure compliance with effective templates 
• Performing proof reading and finalize document for final processing in Veeva QDocs 
• Developing, updating, managing, and maintaining GxP controlled documents in close cooperation with functional area representatives  
• Developing SOPs and WIs to support Quality Systems and Veeva Document control processes 
• Assisting and training end users in Veeva to execute document review, approval and troubleshoot as needed 
• Maintaining document control compliance KPIs such as periodic review and compiling and reporting metrics for management review. 
• Partnering with IT to support Veeva system change control activities for system process enhancements/improvements and new release validation. 
• Serving as backup Veeva Quality Training Administrator and supporting creation of training assignments as needed
• Performing other duties and complete special projects as required

Ideal Candidate Profile >>> 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge

• Bachelor’s Degree is required
• Experience in managing and maintaining GxP compliance documents and Document Control systems
• Strong knowledge of GxP/FDA regulations and experience in supporting regulatory inspections

Experience

• 8+ years of industry experience
• 2+ years as Veeva Vault QDocs Administrator
• Experience in managing and maintaining GxP documents and Document Control systems
• Experience establishing effective KPIs for document management system
• Experience creating and facilitating training for Quality Systems

Attributes

• Strong written and verbal communication and interpersonal skills
• Commitment to supporting internal and external teams and customers
• Demonstrates strong autonomy and initiative
• Meticulous attention to detail and well organized
• Ability to multi-task, shift priorities, work in a fast-paced environment, and adeptly solve problems
• Effectively collaborate as a team player in a highly matrixed organization, demonstrating professional demeanor, enthusiasm, and self-motivation

The base pay range for this position is expected to be $150,000 - $160,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

About the Role >>> Senior Manager, Quality Document Control and Compliance 

The Senior Manager, Quality Document Control and Compliance will report to the Director, Quality Systems and lead and manage the daily activities of Veeva Vault QDocs and overall document management process and compliance. This role includes but not limited to: creation and processing of document change control documentation in Veeva QDocs, management of standard operating procedures (SOPs) and other GXP documentation, GXP record processing and archival, maintain document control compliance KPIs and compile and report metrics for management review. 

This role is based out of our San Francisco, CA or Cambridge, MA office and will require about 15% travel. 

Your work will primarily encompass: 

• Serving as Veeva Vault QDocs Administrator and document control manager  
• Processing document change control (DCC) in Veeva for GxP controlled documents
• Formatting the finalized documents to ensure compliance with effective templates 
• Performing proof reading and finalize document for final processing in Veeva QDocs 
• Developing, updating, managing, and maintaining GxP controlled documents in close cooperation with functional area representatives  
• Developing SOPs and WIs to support Quality Systems and Veeva Document control processes 
• Assisting and training end users in Veeva to execute document review, approval and troubleshoot as needed 
• Maintaining document control compliance KPIs such as periodic review and compiling and reporting metrics for management review. 
• Partnering with IT to support Veeva system change control activities for system process enhancements/improvements and new release validation. 
• Serving as backup Veeva Quality Training Administrator and supporting creation of training assignments as needed
• Performing other duties and complete special projects as required

Ideal Candidate Profile >>> 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge

• Bachelor’s Degree is required
• Experience in managing and maintaining GxP compliance documents and Document Control systems
• Strong knowledge of GxP/FDA regulations and experience in supporting regulatory inspections

Experience

• 8+ years of industry experience
• 2+ years as Veeva Vault QDocs Administrator
• Experience in managing and maintaining GxP documents and Document Control systems
• Experience establishing effective KPIs for document management system
• Experience creating and facilitating training for Quality Systems

Attributes

• Strong written and verbal communication and interpersonal skills
• Commitment to supporting internal and external teams and customers
• Demonstrates strong autonomy and initiative
• Meticulous attention to detail and well organized
• Ability to multi-task, shift priorities, work in a fast-paced environment, and adeptly solve problems
• Effectively collaborate as a team player in a highly matrixed organization, demonstrating professional demeanor, enthusiasm, and self-motivation

The base pay range for this position is expected to be $150,000 - $160,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

About the Role >>> Senior Clinical Trial Associate 

As the Senior Clinical Trial Associate reporting to the Senior Manager, Clinical Trial Leader, you will provide comprehensive administrative and operational support to clinical team members across all study activities, including both in-house and outsourced trials. This role supports cross-functional study execution through coordination with internal teams, external vendors, and site staff, and may include contributing to study documentation such as informed consent forms (ICFs) and central IRB submissions, supporting site payments and other study-related operational activities, as well as liaising with and following up with investigator sites. Responsibilities include assisting with study start-up, maintenance, and closeout activities; managing study documentation and materials; supporting vendor management; and maintaining study trackers and financial records. This position adheres to Clinical Standard Operating Procedures and Good Clinical Practice (ICH) guidelines. 

This role is based out of either our office San Francisco or Cambridge office and will require approximately 10% travel. 

Your work will primarily encompass: 

• Supports the Clinical Trial Lead (CTL) and Study Execution Team (SET), ensuring ongoing accurate and essential documentation of study conduct 
• Manages study-related vendors and serves as a point of contact for contracted CROs, study staff, contract labs, and other study vendors 
• Acts as a key point of contact for investigator sites, facilitating communication, and ensuring effective coordination of study-related activities
• Conducts oversight of sample collection, shipment, and analyses 
• Conducts reconciliation and tracking of study processes in collaboration with study team and escalates issues in a timely fashion to study lead 
• Identifies potential risks and proactively resolves issues with CROs 
• Assists in the development of vendor management and other study plans and compiles study and quality metrics for CTL, management, and/or team review(s) 
• Facilitates flow and maintenance of correspondence with vendors and sites to provide or obtain study-specific information 
• Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents  
• Assists in coordination of study initiation documentation materials, including support for central IRB submission documents and review of site-specific informed consent forms. 
• Coordinates electronic distribution and/or shipment of study-related materials, as appropriate  
• Collaborates with relevant team members in the coordination and tracking of vendor and investigator site contracts, budgets, invoices, and/or payments as needed 
• Contributes to the development of the TMF plan and conducts periodic quality control reviews and records reconciliation of the Trial Master File (TMF)  
• Performs study and departmental administrative and clerical duties such as preparing agendas and minutes for team meetings and providing meeting planning and presentations 
• Actively participates in department initiatives and goals, providing suggestions that support the vision, mission, and enhancement of Clinical Operations; may lead certain SOPs or other processes

Ideal Candidate Profile >>>   

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge

• Bachelor’s degree is required 
• Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines is preferred 
• Working knowledge of clinical protocols 

Experience

• Minimum of 3 years of related industry experience is required 
• Senior CTA requires 2 years' experience working as a Clinical Trial Associate. 
• Proficiency with Microsoft applications (e.g., Microsoft Word, Excel, PowerPoint, Outlook) 
• Experience with leading small group meetings and/or managing vendor relationships 

Attributes

• Highly motivated and enjoys working in a fast-paced, dynamic environment 
• Excellent teamwork and collaboration skills 
• Good organizational skills, ability to manage multiple tasks and meticulous attention to detail 
• Excellent written and verbal communication skills 
• Ability to accommodate a flexible work schedule according to clinical trial(s) priorities, as needed 

The base pay range for this position is expected to be $110,000 - $120,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

About the Role >>> Program Manager, CMC 

As the Program Manager, CMC reporting to the Director, CMC Program Management, you will lead integrated CMC program planning and execution across clinical development stages. You will translate CMC strategy into actionable, integrated plans that enable timely clinical and regulatory progress. This role is highly cross-functional and requires close collaboration with Technical Operations (CMC technical leads), Quality, Regulatory, Supply Chain, Finance and external partners. You will serve as an operational leader – driving accountability, facilitating alignment, managing risk, and helping teams navigate challenges effectively.   

This role can be based out of our San Francisco, CA or Boston, MA offices and will require 10% travel. 

Your work will primarily encompass:

• Lead integrated CMC planning across Drug Substance (DS), Drug Product (DP), Analytical (AC), Quality (QA), Regulatory (RA), and Supply Chain (SC), partnering with Director- and Senior Director-level functional leaders to define deliverables, timelines, and priorities aligned to clinical and regulatory goals. 
• Build and maintain integrated project timelines in Smartsheet (or similar tools), ensuring dependencies, critical path activities, and milestones are clearly defined and tracked. 
• Identify program risks, drive mitigation planning with functional leads, and escalate issues as needed to maintain timelines. 
• Facilitate CMC sub-team meetings, document decisions and action items, and ensure follow-through across internal teams and external partners. 
• Prepare leadership-ready status updates and presentations, track key program metrics, and maintain clear documentation of plans, risks, and decisions. 
• Support regulatory submission readiness by aligning CMC deliverables, documentation, and cross-functional inputs to filing timelines. 
• Partner with Technical Operations and CDMOs to drive coordinated execution and proactively identify risks to supply or compliance. 
• Strengthen CMC program management practices, tools, and planning processes to support scalable, efficient execution. 
• Provide program-level budget visibility and tracking in collaboration with functional leads and Finance. 
• Contribute to a collaborative, accountable, and team-oriented culture within CMC and across Olema. 

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor's degree required, Life Sciences or related disciplines preferred. 
• Proficiency in Microsoft Office Suite (PowerPoint, Excel, Outlook), Smartsheet (or equivalent PM tools), and collaboration platforms (e.g., MS Teams, SharePoint). 
• Knowledge of CMC development processes across clinical stages. 
• Familiarity with regulatory submission timelines and CMC documentation requirements preferred. 

Experience: 

• Minimum 5+ years of experience in life sciences program management and/or drug development operations with a bachelor's degree, or 3+ years with a master's degree. 
• Experience driving CMC execution in early clinical-stage development (Phase 1–2), with exposure to Phase 3 readiness considered a plus. 
• Working cross-functionally within drug development teams (Drug Substance, Drug Product, Analytical, Quality, Regulatory Affairs, Supply chain). 
• Demonstrated experience building and managing integrated project plans, identifying critical path activities, and proactively managing risks and dependencies. 
• Collaborating and interacting with external vendors/CDMOs. 
• Experience preparing materials for team or leadership meetings. 

Attributes: 

• Highly organized with strong attention to detail and follow-through. 
• Energetic, proactive, and action-oriented — a true “go-getter.” 
• Friendly and approachable with a collaborative mindset. 
• Strong communicator who can tailor messaging to diverse audiences. 
• Skilled at bridging functions and building strong working relationships. 
• Comfortable navigating a fast-paced, evolving environment. 
• Solutions-oriented with sound judgment and appropriate escalation. 
• Strong team player who thrives in highly collaborative settings. 

The base pay range for this position is expected to be $150,000-$170,00 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MT1

About the Role >>> Associate Director, GMP Quality – Qualified Person

As the Qualified Person (QP), reporting to the Senior Director, Quality Assurance based in San Francisco, California, USA you will hold responsibility for ensuring that Clinical and Commercial medicinal products are manufactured, tested and released in compliance with applicable regulatory requirements of the European Union. You will also ensure that the products are prepared for certification by QPs of the United Kingdom and Israel and are compatible with U.S requirements.

You will be responsible for conducting Supplier and Contract Service Provider audits within the European Economic Community and other geographies. You will monitor changes to European regulatory requirements and host any inspections conducted by the Health Product Regulatory Authority (HPRA) or other Competent Authorities of the European Union. You will be an integral participant in annual Quality System reviews, including Quality Management Review (QMR) and Annual Product Reviews (APRs) following commercial launch. You will work closely with our European CDMOs may also support the processing of European Product Complaints.

This role is based out of our Dublin, Ireland office location and will require up to 25% travel, including some international.

Your work will primarily encompass:

Batch Certification

• Ensure all manufacturing and testing activities comply with approved procedures, Investigational Medicinal Product Dossiers and regulatory standards
• Ensure that outsourced manufacturing and testing activities meet GMP and quality standards
• Act as the legally accountable person for batch certification (as per Directive 2001/83/EC, where applicable)
• Certify and release batches of medicinal products in accordance with EU GMP, Marketing Authorization (MA), and regulatory requirements

Supplier Quality Management

• In conjunction with U.S. based Compliance functions, provide Supplier and CSPs quality and compliance oversight
• Establish appropriate assessment mechanisms, risk-based controls, and monitoring and feedback loops to ensure compliant, effective oversight
• Serve as a resource for the conduct of audits and other assessments of both suppliers and business partners
• Process Supplier Corrective Action Requests (SCARs) and External Change Notifications (ECNs)

And will also include:

Inspection Readiness

• Establish and maintain the infrastructure and processes required to prepare Olema’s European affiliate for HPRA and other Competent Authorities of the European Union
• Utilize electronic systems, including Artificial Intelligence–enabled tools, to support inspection readiness activities
• Utilize Inspection Management Software to ensure consistent and reliable inspection preparation and response
• Perform Mock Inspections at European Suppliers / CSPs / Partners

Regulatory Intelligence and Monitoring

• Monitor local and European regulatory authorities for proposed GMP rulemaking and or trends in regulatory inspections
• Monitor inspectional status and compliance trends within the Olema European Supplier and CSP network

Annual Reviews and Quality System Leadership

• Participate in the annual Quality Management Review process
• Participate in the execution of Annual Product Quality Reviews upon commercial product launch
• Collaborate with Quality Systems to plan and deliver annual GxP topical training for relevant functions on European topics

As this is a new office, there may be other assignments and projects as required.

Ideal Candidate Profile >>>

A strong contributor with in-depth knowledge. A confident professional with a solid understanding of EU and UK regulatory GMP compliance requirements. A team-oriented individual with solid ability to communicate across multiple time zones, strong work ethic, optimism, and commitment to meaningful contributions. As such, we are looking for someone with the right combination of qualifications, knowledge, experience, and attributes for this role.

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Qualifications

• Eligible to act as a Qualified Person under EU legislation (Directive 2001/83/EC)
• Pharmaceutical Quality System (PQS) Auditor certification is highly preferred

Knowledge

• Bachelor's degree in pharmacy, chemistry, biology or a related scientific field is required
• Strong understanding of EU and Rest-of-World (ROW) regulatory and compliance requirements
• Demonstrated experience in Supplier Compliance and Inspection Management
• Firm knowledge of GMPs, GDPs and Quality Management Systems
• Experience using Inspection Management Software

Experience

• Minimum 10 years of experience in Biopharmaceutical industry
• Minimum 7 Years of experience in Supplier Quality Management
• Minimum 3 Years of experience with Oral Solid Dosage forms
• Minimum 4 Years of experience in a Qualified Person role
• Oncology experience is desirable

Attributes

• Self-directed and capable of independently setting and managing priorities
• Able to adapt to a rapidly changing organization characterized by ambiguity and evolving process definition
• Demonstrates strong cross-functional collaboration, and communication skills
• Comfortable adopting new technologies and tailoring them to Olema’s Quality and Compliance needs
• Critical thinking, able to identify the gates required for QP certification
• Passionate about meaningful work and contributing to patient-focused outcomes

#LI-MK1

About the Role >>> Program Manager, CMC 

As the Program Manager, CMC reporting to the Director, CMC Program Management, you will lead integrated CMC program planning and execution across clinical development stages. You will translate CMC strategy into actionable, integrated plans that enable timely clinical and regulatory progress. This role is highly cross-functional and requires close collaboration with Technical Operations (CMC technical leads), Quality, Regulatory, Supply Chain, Finance and external partners. You will serve as an operational leader – driving accountability, facilitating alignment, managing risk, and helping teams navigate challenges effectively.   

This role can be based out of our San Francisco, CA or Boston, MA offices and will require 10% travel. 

Your work will primarily encompass:

• Lead integrated CMC planning across Drug Substance (DS), Drug Product (DP), Analytical (AC), Quality (QA), Regulatory (RA), and Supply Chain (SC), partnering with Director- and Senior Director-level functional leaders to define deliverables, timelines, and priorities aligned to clinical and regulatory goals. 
• Build and maintain integrated project timelines in Smartsheet (or similar tools), ensuring dependencies, critical path activities, and milestones are clearly defined and tracked. 
• Identify program risks, drive mitigation planning with functional leads, and escalate issues as needed to maintain timelines. 
• Facilitate CMC sub-team meetings, document decisions and action items, and ensure follow-through across internal teams and external partners. 
• Prepare leadership-ready status updates and presentations, track key program metrics, and maintain clear documentation of plans, risks, and decisions. 
• Support regulatory submission readiness by aligning CMC deliverables, documentation, and cross-functional inputs to filing timelines. 
• Partner with Technical Operations and CDMOs to drive coordinated execution and proactively identify risks to supply or compliance. 
• Strengthen CMC program management practices, tools, and planning processes to support scalable, efficient execution. 
• Provide program-level budget visibility and tracking in collaboration with functional leads and Finance. 
• Contribute to a collaborative, accountable, and team-oriented culture within CMC and across Olema. 

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor's degree required, Life Sciences or related disciplines preferred. 
• Proficiency in Microsoft Office Suite (PowerPoint, Excel, Outlook), Smartsheet (or equivalent PM tools), and collaboration platforms (e.g., MS Teams, SharePoint). 
• Knowledge of CMC development processes across clinical stages. 
• Familiarity with regulatory submission timelines and CMC documentation requirements preferred. 

Experience: 

• Minimum 5+ years of experience in life sciences program management and/or drug development operations with a bachelor's degree, or 3+ years with a master's degree. 
• Experience driving CMC execution in early clinical-stage development (Phase 1–2), with exposure to Phase 3 readiness considered a plus. 
• Working cross-functionally within drug development teams (Drug Substance, Drug Product, Analytical, Quality, Regulatory Affairs, Supply chain). 
• Demonstrated experience building and managing integrated project plans, identifying critical path activities, and proactively managing risks and dependencies. 
• Collaborating and interacting with external vendors/CDMOs. 
• Experience preparing materials for team or leadership meetings. 

Attributes: 

• Highly organized with strong attention to detail and follow-through. 
• Energetic, proactive, and action-oriented — a true “go-getter.” 
• Friendly and approachable with a collaborative mindset. 
• Strong communicator who can tailor messaging to diverse audiences. 
• Skilled at bridging functions and building strong working relationships. 
• Comfortable navigating a fast-paced, evolving environment. 
• Solutions-oriented with sound judgment and appropriate escalation. 
• Strong team player who thrives in highly collaborative settings. 

The base pay range for this position is expected to be $150,000-$170,00 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MT1